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| Name | Class |
|---|---|
| Exegi Pharma | UNKNOWN |
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The goal of this pilot study is to explore a combination of two interventions: (1) a behavioral alcohol-reduction intervention using motivational interviewing, and (2) a blinded probiotic microbiome or placebo intervention. The study examines whether these interventions improve cognitive and neurophysiological function, including brain metabolism, in older adults who are high-risk alcohol drinkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing + Probiotic | Experimental | Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive an active probiotic supplement 900 billion colony forming units (CFU), once daily. |
|
| Motivational Interviewing + Placebo | Placebo Comparator | Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive a placebo supplement once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visbiome | Dietary Supplement | Participants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cognition Composite score | Cognitive performance will be assessed using the NIH Toolbox Cognition Battery v3 to measure the Total Cognition Composite score at two time-points and examined for change within subjects. | Baseline, 30 days |
| Change in Brain Metabolism | Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake. | Baseline, 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teddy Salan, PhD | Contact | 305-243-9228 | txs785@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Teddy Salan, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| Motivational Interviewing | Behavioral | Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes |
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| Placebo | Other | Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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